Prevention of Drug Induced Ototoxicity in Peritoneal Dialysis Patients by N-Acetylcysteine
Information source: TC Erciyes University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Drug-induced Ototoxicity in Peritoneal Dialysis Patients
Intervention: N-acetylcysteine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: TC Erciyes University Official(s) and/or principal investigator(s):
Bulent Tokgoz, MD, Principal Investigator, Affiliation: Erciyes University School of Medicine
Summary
The purpose of this study is to determine whether N-acetylcysteine is effective in the
prevention of hearing loss in both ears due to aminoglycoside and/or vancomycine induced
ototoxicity in peritoneal dialysis patients.
Clinical Details
Official title: The Evaluation of the Protective Effect of N-Acetylcysteine Against Drug Induced Ototoxicity in Peritoneal Dialysis Patients
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- End-stage renal disease
- Undergoing continuous ambulatory peritoneal dialysis as a renal replacement therapy
- Clinical diagnosis of a peritonitis episode in a continuous ambulatory peritoneal
dialysis patient
- Developing the first continuous ambulatory peritoneal dialysis related peritonitis
episode
Exclusion Criteria:
- Being treated with aminoglycoside antibiotics and vancomycine within the previous 3
months
- Detection of mechanical occlusion of external ear
- Having signs of disturbed integrity of tympanic membrane on otoscopy or tympanometry
- History of a continuous ambulatory peritoneal dialysis related peritonitis
Locations and Contacts
Erciyes University School of Medicine Department of Nephrology, Kayseri 38039, Turkey
Additional Information
Starting date: February 2008
Last updated: May 26, 2010
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